Systems and methods to identify and disable re-use single use devices based on detecting environmental changes

ABSTRACT

A medical system for limiting usage of a medical probe, such as, e.g., a catheter or a surgical probe, is provided. The medical system comprises a medical probe that includes an electronic storage component for storage of data. The electronic storage component has environmental sensing capabilities and detects an environmental condition to which the medical probe is exposed. If the detected environmental condition is associated with a sterilization cycle, the electronic storage component stores a probe sterilization indicator indicating that the medical probe has been sterilized. The medical system further includes a medical probe control unit to which the medical probe is connected. The medical probe control unit is configured for writing and reading data to and from the electronic storage component of the medical probe when the medical probe is connected to the control unit. The medical probe control unit comprises a control circuit that prevents operation of the medical probe based on the presence of the probe sterilization indicator. Prevention of the medical probe operation is also based on a probe usage indicator, which is employed to distinguish between legitimate and illegitimate sterilization of medical probes.

FIELD OF THE INVENTION

The present invention is directed to medical systems, and morespecifically, to systems, apparatus and methods for limiting there-usage of medical probes, such as catheters and surgical probes.

BACKGROUND

Catheters, surgical probes and related probe devices (collectivelyreferred to, hereinafter, as “medical probes” or “probes”) are usedtoday in diagnostic and therapeutic medical procedures that requiresurgical or minimally invasive access to target tissue areas withininterior regions of the body. During these procedures, a physicianlocates the distal end of the medical probe at the target site by, inthe case of a catheter, steering the medical probe through a main veinor artery (typically, the femoral vein or artery), or, in the case of asurgical probe, advancing the medical probe through the surgical openingleading to the target site.

The physician then operates the medical probe to activate a functionalcomponent mounted at the probe distal end, thereby providing therapeutictreatment to and/or diagnosis of the interior region. Due to thepotential of passing any of a variety of dangerous diseases from onepatient to another, prudent consideration dictates that the reuse ofsuch probes should be prevented or, at the least, minimized. Typically,medical probes that are re-used are sterilized between uses to kill anydisease-causing agents and to remove any tissue that has collected onthe medical probe during the previous use. Sterilization of used medicalprobes, however, is not fool-proof, and oftentimes ineffective whentissue located on the medical probe is not exposed to the full effect ofthe sterilization process. Thus, even a sterilized medical probe maypose a threat to patients.

Minimizing re-use of medical probes that provide therapy becomes evenmore critical. During the therapeutic process, it is important for thephysician to control the therapeutic component at the probe distal endcarefully and precisely, so that adverse damage to a therapeuticcomponent of the medical probe does not occur. Sterilization of andre-use of therapeutic medical probes subjects the therapeutic componentto mechanical, chemical and/or thermal stress, thus jeopardizing thecontrol that the physician may have of the therapeutic component.

The need for careful and precise control over a therapeutic medicalprobe is especially critical during procedures that ablate tissue withinthe heart. These procedures, called electrophysiological therapy, arebecoming more widespread for treating cardiac rhythm disturbances. Wheninside the desired chamber of the heart, the physician manipulates asteering mechanism to place one or more electrodes located at the distalend of the medical probe into direct contact with the heart tissue to beablated. The physician then directs radio frequency energy from theelectrodes through the tissue to an indifferent electrode, therebyablating the tissue and forming a lesion. If the electrodes or theelectrical wires connected thereto are worn or faulty, however, ablationmay be ineffective and, in the worst case, may cause charring of theheart tissue.

Preventing or limiting re-usage of medical probes, while still allowinglegitimate use of these probes, is made difficult by a possible scenariowherein the physician uses the medical probe, temporarily disconnectsthe probe from the control unit, and reconnects the probe to the controlunit to continue the procedure. Thus, there is a danger of deeming thecontinued procedure to be re-usage of the medical probe, which mayresult in the probe being rendered prematurely inoperable.

Thus, it would be desirable to provide an improved medical system forminimizing the re-usage of medical probes, while still allowinglegitimate use of these probes.

SUMMARY OF THE INVENTION

The present invention is directed to improved apparatus and methods forlimiting the usage of medical probes, such as, e.g., catheters andsurgical probes.

In a preferred method performed in accordance with a first aspect of theinvention, the sterilization of a medical probe is monitored bydetecting an environmental condition to which the medical probe isexposed, electronically storing a probe sterilization indicator with themedical probe if the detected environmental condition indicates exposureof the medical probe to a sterilization cycle and determining thepresence of the probe sterilization indicator. By way of non-limitingexample, either temperature, moisture, pressure and/or a chemical is thedetected environmental condition. The medical probe is conditionallyoperated based on the presence of the probe sterilization indicator. Theoperation of the medical probe may also be based on the presence of aprobe usage indicator, which indicates if the medical probe has beenpreviously operated.

In another preferred method performed in accordance with a furtheraspect of the invention, the usage of a medical probe is limited bydetecting an environmental condition to which the medical probe isexposed, electronically storing a probe sterilization indicator in themedical probe if the detected environmental condition indicates exposureof the medical probe to a sterilization cycle, determining a presence ofthe medical probe indicator, and conditionally operating the medicalprobe based on the presence of the probe sterilization indicator. Aprobe usage indicator indicating that the medical probe has beenoperated can be stored in the medical probe. Conditional operation ofthe medical probe can also be based on the probe usage indicator.Alternatively, an estimated probe sterilization date or probemanufacture date can be stored in the medical probe when the medicalprobe is manufactured, and an actual probe sterilization date can bestored in the medical probe upon actual sterilization of the medicalprobe. Conditional operation of the medical probe can be based on theestimated probe sterilization date and the actual probe sterilizationdate. By way of non-limiting example, the medical probe can be preventedfrom being operated if the actual probe sterilization date is later thanthe estimated probe sterilization date. Optionally, the actual probesterilization date can be used to enforce the shelf-life of the medicalprobe. By way of non-limiting example, operation of the medical probecan be prevented if the difference between the actual probesterilization date and a reference date, such as, e.g., the currentdate, is greater than a predetermined period of time.

In a preferred embodiment constructed in accordance with still anotheraspect of the invention, a control unit for connection to a medicalprobe having electronic storage componentry, comprises control circuitryconfigured to electrically couple to the electronic storage componentryfor reading data from the electronic storage componentry, and forconditionally operating the medical probe based on a presence of a probesterilization indicator in the data. By way of non-limiting example, thepreferred embodiment of the control unit is an RF generator having amicroprocessor as the control circuitry. The microprocessor isconfigured for conditionally operating the medical probe based on thepresence of the probe sterilization indicator. The microprocessor canalso be configured for conditionally operating the medical probe basedon the presence of a probe usage indicator indicating previous operationof the medical probe. When the medical probe is operated, and morepreferably, when the medical probe is effectively operated, the probeusage indicator is stored in the electronic storage componentry and theprobe sterilization indicator is cleared.

In another preferred embodiment constructed in accordance with still afurther aspect of the invention, a medical probe includes an elongatemember carrying electronic storage componentry configured for detectingan environmental condition to which the medical probe is exposed andstoring a probe sterilization indicator in the medical probe if thedetected environmental condition indicates exposure of the medical probeto a sterilization cycle. By way of non-limiting example, in thepreferred embodiment, the electronic storage component is a non-volatilestorage component, such as, e.g., nonvolatile RAM and a battery.Alternatively, the non-volatile storage components can comprise othercomponents that have environmental sensing capabilities. For example,the non-volatile component can comprise an electrolytic sensor orchemfet.

Other and further objects, features, aspects, and advantages of thepresent invention will become better understood with the followingdetailed description of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate both the design and utility of preferredembodiments of the present invention, in which:

FIG. 1 is a perspective view of an embodiment of a catheter system inaccordance with various aspects of the present invention;

FIG. 2 is a schematic of a preferred embodiment of a medical probesystem;

FIG. 3 is a flow diagram of a preferred method of conditionallyoperating a medical probe employed in the medical probe system of FIG.2;

FIG. 4 is a schematic of an alternative preferred embodiment of amedical probe system;

FIG. 5 is a flow diagram of a preferred method of storing a probesterilization indicator within a medical probe employed in the medicalprobe system of FIG. 4;

FIG. 6 is a flow diagram of a preferred method of conditionallyoperating a medical probe employed in the medical probe system of FIG.4;

FIG. 7 is a schematic of another alternative preferred embodiment of amedical probe system;

FIG. 8 is a schematic of a catalog employed in the medical probe systemof FIG. 7;

FIG. 9 is a flow diagram of a preferred method of obtaining historicaloperational information and conditionally operating the medical probeemployed in the medical probe system of FIG. 7;

FIG. 10 is a schematic of still another alternative preferred embodimentof a medical probe system;

FIG. 11 is a flow diagram of a preferred method of conditionallyoperating a medical probe employed in the medical probe system of FIG.10; and

FIG. 12 is a perspective view of an embodiment of a surgical probesystem in accordance with various aspects of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Catheter System

FIG. 1 depicts a preferred embodiment of a catheter system 10constructed in accordance with the present invention. The system 10generally includes a radiofrequency generator 12, which delivers radiofrequency energy, and a steerable catheter 14 carrying a radiofrequencyemitting tip ablation electrode 16.

In the illustrated embodiment, the system 10 operates in a monopolarmode. In this arrangement, the system 10 includes a skin patch electrodethat serves as an indifferent second electrode 18. In use, theindifferent electrode 18 is attached to the patient's back or otherexterior skin area. Alternatively, the system 10 can be operated in abipolar mode. In this mode, the catheter 14 carries both electrodes. Inthe illustrated embodiment, the ablation electrode 16 and theindifferent electrode 18 are made of platinum. The catheter 14 carries atemperature sensor 19 (shown in FIG. 2) adjacent the ablation electrode16 to measure the temperature to which the tissue is exposed to duringablation.

The catheter 14 further includes a handle 20, a guide tube 22, and a tip24, which carries the ablation electrode 16. The handle 20 encloses asteering mechanism 26 for the catheter tip 24. A cable 28 extending fromthe rear of the handle 20 has plugs (not shown). The plugs connect thecatheter 14 to the generator 12 for conveying radiofrequency energy tothe ablation electrode 16. The radiofrequency energy heats the tissue toform the lesion.

Left and right steering wires (not shown) extend through the guide tube22 to interconnect the steering mechanism 26 to the left and right sidesof the tip 24. Rotating the steering mechanism 26 to the left pulls onthe left steering wire, causing the tip 24 to bend to the left. Also,rotating the steering mechanism 26 to the right pulls on the rightsteering wire, causing the tip 24 to bend to the right. In this way, thephysician steers the ablation electrode 16 into contact with the tissueto be ablated.

Upon initial power on, the generator 12 is placed in a standby mode,which allows the physician to adjust the setpoint parameters. Thesesetpoint parameters include the magnitude of the RF power delivered,tissue temperature and duration of RF power delivery.

The RF power delivered by the generator 12 is set using a power controlinput 30. The actual RF-power delivered by the generator 12 is reportedby a power meter 32. During RF energy delivery, the generator 12 adjustspower output to maintain an actual measured temperature at thetemperature setpoint. Thus, the measured power may be lower than thesetpoint power depending on the measured tissue temperature and/ortissue impedance.

The desired temperature to which the ablated tissue is exposed is setusing a temperature control input 34. The actual temperature to whichthe ablated tissue is exposed is reported by a temperature gauge 36. Thedesired duration of RF power application is set using a timer 38. Acounter 40 tracks the elapsed time from initial delivery of RF power tothe tissue, and counts from zero to the setpoint duration. When loss ofcontact with tissue is detected, the counter 40 stops. Contact betweenthe ablation electrode 16 and the tissue is measured with an impedancemeter 42.

The generator 12 includes an RF power control button 44, the depressionof which places the generator 12 in deliver mode. While in the delivermode, the generator 12 delivers RF energy to the tissue in contact withthe ablation electrode 16 until the count displayed by the counter 40reaches the setpoint duration or until the RF power control button 44 isdepressed again.

Medical Probe System

FIG. 12 depicts a preferred embodiment of a surgical probe system 200constructed in accordance with the present invention. The surgical probesystem 200 is similar to the catheter system 10 described above.Accordingly, elements of the surgical probe system 200 that are similarto those of the catheter system 10 have been given common referencenumbers. Like the catheter system 10, the system 200 includes aradiofrequency generator 12, the details of which are described above.The system 200 further includes a surgical probe 202 that includes arelatively short, relatively stiff shaft 204, a handle 206, and a distalsection 208. The shaft 204 may be from about 4 inches to 18 inches inlength and is preferably about 6 to 8 inches. The distal section 208 maybe from about 1 inch to 10 inches in length and is preferably about 4 to6 inches. The shaft 204 supports a radiofrequency emitting tip ablationelectrode 16, much like that described above, and a plurality of coilelectrodes 210. This embodiment is particularly useful because it can beeasily inserted into the patient through an introducing port such as atrocar.

Additional information concerning the above-described and other surgicalprobes may be found in U.S. application Ser. No. 09/072,872, filed May5, 1998, entitled “Surgical Method and Apparatus for Positioning aDiagnostic or Therapeutic Element Within the Body,” which isincorporated herein by reference.

Interaction between the surgical probe 202 and the RF generator 12 issimilar to that described above between the catheter 14 and the RFgenerator 12. For purposes of brevity, such operation will not berepeated.

Referring to FIG. 2, a medical probe system 300, which can take the formof the catheter system 10 or surgical probe system 200 described above,is depicted. A medical probe 302 (i.e., the catheter 14 or surgicalprobe 202) includes a probe identification component 50, which iscapable of storing a probe identification code C_(I). The probeidentification code C_(I) uniquely identifies the medical probe 302,such as by a serial number, or uniquely identifies a characteristic ofthe medical probe 302, such as, e.g., a particular performance and/orphysical characteristic of the medical probe 302. In the illustratedembodiment, the probe identification component 50 is a non-volatilestorage component, and particularly is a non-solid state device, suchas, e.g., one or more resistors, the resistance value of whichrepresents the probe identification code C_(I). Alternatively, the probeidentification component 50 is a microchip, such as, e.g., a ROM, whichhas been pre-programmed with a digital identification code C_(I).

The medical probe 302 further includes a probe usage limitationcomponent 51. In this embodiment, the probe usage limitation component51 is a non-volatile electronic storage component that is capable ofstoring data. Of course, the entire data need not be stored in a singlecomponent, but may be stored in several components without straying fromthe principles taught by this invention. For purposes of illustration,the probe identification component 50 and the probe usage limitationcomponent 51 are depicted as separate components. It should.be noted,however, that the functions performed by the probe identificationcomponent 50 and the probe usage limitation component 51 can, in mostinstances, be performed within a single component.

Limiting Re-use of Devices Based on Time Elapsed From First Use

The medical probe system 300 is capable of identifying and disablingre-used single use devices based on the time elapsed from the firsttherapeutic use of the medical probe 302. In this regard, theprobe-usage limitation component 51 is able to store an initial probeusage time T_(I) and a predetermined elapsed time limit T_(L). Theinitial probe usage time T_(I) is written into the probe usagelimitation component 51 by the generator 12 when the medical probe 302is initially operated. Subsequently, the initial probe usage time T_(I)can be read from the probe usage limitation component 51 and used tolimit re-usage of the medical probe 302, based on the initial operationof the medical probe 302.

Utility of storing the initial probe usage time T_(I) within the probeusage limitation component 51, however, is not to be limited to limitingre-usage of the medical probe 302, but may extend to any applicationwherein knowledge of the time of the initial operation of the medicalprobe 302 would be useful. For example, the initial probe usage timeT_(I) can be read from a faulty medical probe to facilitatetroubleshooting of the medical probe. The predetermined elapsed timelimit T_(L) is written into the probe usage limitation component 51,preferably during the manufacturing process. The predetermined elapsedtime limit T_(L) represents the amount of time after the medical probehas been initially operated that the medical probe remains operable.Preferably, the value of the predetermined elapsed time limit T_(L) isselected to minimize reuse of the medical probe 302, while stillallowing legitimate use of the medical probe 302. For example, the valueof the predetermined elapsed time limit T_(L) can be selected to bebetween the maximum time expected to perform a therapeutic ablationprocedure on a patient and the minimum time expected to complete asterilization cycle on the medical probe 302. By way of non-limitingexample, the value of the predetermined elapsed time limit T_(L) can beselected to be 24 hours.

In the illustrated embodiment, the probe usage limitation component 51comprises an EEPROM. Preferably, the probe usage limitation component 51includes temperature-sensing capability to provide a known referencetemperature T_(I) for the temperature sensor 19, which, in theillustrated embodiment, is a thermocouple having a firsttemperature-sensing element 21 located adjacent the ablation electrode16, and a second temperature-sensing element 23 located in the handle 20(shown in FIG. 1) adjacent the probe usage limitation component 51. Inthis manner, the need for a thermistor, which was previously used tomeasure the reference temperature adjacent the secondtemperature-sensing element 23, is obviated. By way of non-limitingexample, a Model DS2434 battery identification chip manufactured byDallas Semiconductor is an EEPROM that provides temperature-sensingcapability.

The structure of the probe usage limitation component 51 is not limitedto an EEPROM, but can take the form of any non-volatile component thatallows storage of data therein on-the-fly. Alternatively, the structureof the probe usage limitation component 51 can comprise othermicrochips, such as, e.g., non-volatile RAM or volatile RAM inconjunction with a battery.

The generator 12 includes an RF power source 52,which is connectedthrough a transformer 54 to first and second conducting lines 56 and 58.In the illustrated environment, the power source 52 delivers up to 150watts of power at a frequency of 500kHz. The first conducting line 56leads to the ablation electrode 16, and the second conducting line 58leads to the indifferent electrode 18. The generator 12 further includesan interlock device 60, which is electrically coupled to the powersource 52. Activation of the interlock device 60 via a control signalprevents the power source 52 from outputting power to the transformer54, thereby preventing delivery of RF energy to the tissue to beablated.

The generator 12 includes a clock 62, which, as will be discussed infurther detail below, generates a time signal T for time-keepingfunctions. In the illustrated embodiment, the time signal T representsan absolute time, such as, e.g., what one may obtain from a standardhousehold clock.

The generator 12 further includes a control circuit 68, which iselectrically coupled to the clock 62 to obtain the time signal T. Thecontrol circuit 68 is electrically coupled to the probe usage limitationcomponent 51 of the medical probe 302 when the medical probe 302 isphysically connected to the generator 12, so that the control circuit 68can read and write data to and from the probe usage limitation component51.

The control circuit 68 is configured for deriving an initial probe usagetime T_(I) from the time signal T when the medical probe is initiallyoperated, and for writing the initial probe usage time T_(I) to theprobe usage limitation component 51, assuming that the probe usagelimitation component 51 has not previously been initialized with theinitial probe usage time T_(I). In this manner, the initial probe usagetime T_(I) is reported to the generator 12 or a like generator if themedical probe 302 is reconnected to the generator 12, i.e., when themedical probe 302 is physically disconnected from the generator 12 andthen physically reconnected to the generator 12 or like generator.

The control circuit 68 is further configured for reading the initialprobe usage time T_(I) from the probe usage limitation component 51, andgenerating an interlock control signal S_(C) based on the initial probeusage time T_(I). In particular, the control circuit 68 is configuredfor reading the predetermined elapsed time limit T_(L) from the probeusage limitation component 51 and determining if the predeterminedelapsed time limit T_(L) has expired. The control circuit 68 determinesexpiration of the predetermined elapsed time limit T_(L) by determiningan elapsed probe usage time T_(E) based on a comparison between initialprobe usage time T_(I) and a reference time T_(R) obtained from the timesignal T, i.e., the initial probe usage time T_(I) is subtracted fromthe reference time T_(R). In the illustrated embodiment, the referencetime T_(R) represents the current absolute time. The control circuit 68then compares the elapsed probe usage time T_(E) with the predeterminedelapsed time limit T_(L) to determine if the predetermined elapsed timelimit T_(L) has expired, i.e., if the elapsed probe usage time T_(E)exceeds the predetermined elapsed time limit T_(L), the predeterminedelapsed time limit T_(L) is considered expired. For the purposes of thisinvention, the value of the elapsed probe usage time T_(E) exceeds thevalue of the predetermined elapsed time limit T_(L) if the value of theelapsed probe usage time T_(E) is equal to or greater than the value ofthe predetermined elapsed time limit T_(L).

The control circuit 68 is electrically coupled to the interlock device60 and applies the interlock control signal S_(C) thereto. Applicationof the interlock control signal S_(C) activates the interlock device 60,preventing power from being outputted from the power source 52, and inturn, preventing subsequent conveyance of RF energy to tissue in contactwith the ablation electrode 16.

With reference to FIG. 3, operation of the medical probe system 300, inidentifying and disabling re-used single use devices based on the timeelapsed from the first therapeutic use of the medical probe 302, willnow be described. Without knowledge of whether the medical probe 302 hasbeen previously operated, the medical probe system 300 is set up byphysically connecting the medical probe 302 to the generator 12 andpowering on the generator 12 (step 70). At this point, the generator 12is in standby mode. The generator 12 then reads the data from the probeusage limitation component 51 (step 72). After insertion of the medicalprobe 302 within the patient's body and placement of the ablationelectrode 16 in contact with the tissue to be ablated, the RF powercontrol button 44 is depressed to conditionally initiate powertransmission from the generator 12 and subsequent delivery of RF energyto the tissue (step 74). At this point, the generator 12 is in deliverymode.

The generator 12 then determines whether the probe usage limitationcomponent 51 has already been initiated with an initial probe usage-timeT_(I) by analyzing the data read from the probe usage limitationcomponent 51 (step 76). If the probe usage limitation component 51 hasnot already been initialized with the initial probe usage time T_(l),the generator 12 initializes the probe usage limitation component 51with the initial probe usage time T_(I) (step 78). That is, thegenerator 12 derives the initial probe usage time T_(I) from the timingsignal T, and writes the initial probe usage time T_(I) into the probeusage limitation component 51 of the medical probe 302. In this manner,if the medical probe 302 is physically disconnected and reconnected tothe generator 12 or like generator and conditionally operated, thegenerator 12 or like generator can ascertain when the medical probe 302was initially operated. Since the medical probe 302 has not beenpreviously operated, the generator 12 then allows operation of themedical probe 302, i.e., the interlock control signal S_(C) is notgenerated (step 88).

In the illustrated embodiment, initialization of the probe usagelimitation component 51 occurs upon effective operation of the medicalprobe 302, i.e., operation of the medical probe 302 in such a manner asto form a lesion on the tissue. In this regard, to prevent prematureinitiation of the probe usage limitation component 51, the generator 12does not write to the probe usage limitation component 51 duringnon-therapeutic operation of the medical probe 302, i.e., when operationof the medical probe 302 does not result in a tissue lesion. Such probeoperation can be caused by a variety of reasons, including inadequatecontact between the ablation electrode 16 and the tissue, inadequateenergy delivery to the ablation electrode 16 and inadequate duration ofenergy application.

After initiation of the probe usage limitation component 51 with theinitial probe usage time T_(I) (step 78), or if the generator 12determines that the probe usage limitation component 51 has already beeninitialized with the initial probe usage time T_(I) (step 76), thegenerator 12 determines whether the predetermined elapsed time limitT_(L) has expired (steps 80-84). First, the reference time T_(R) isdetermined from the time signal T (step 80). Then, the elapsed probeusage time T_(E) is determined by subtracting the initial probe usagetime T_(I) from the reference time T_(R) (step 82). Then, the elapsedprobe usage time T_(E) is compared to the predetermined elapsed timelimit T_(L) (step 84).

If the elapsed probe usage time T_(E) exceeds the predetermined elapsedtime limit T_(L), the generator 12 prevents operation of the medicalprobe 302, i.e., the interlock control signal S_(C) is generated, whichis subsequently transmitted to the interlock device 60 (step 86). Themedical probe 302 is thus rendered inoperable and cannot be re-used,thereby preventing further operation of the medical probe 302. If thevalue of the elapsed probe usage time T_(E) does not exceed the value ofthe predetermined elapsed time limit T_(L), the generator 12 allowsoperation of the medical probe 302, i.e., the interlock control signalS_(C) is not generated (step 88).

The generator 12 periodically (e.g., every second) determines if theelapsed probe usage time T_(E) has expired and conditionally allowsoperation of the medical probe 302, based on the expiration of theelapsed probe usage time T_(E), until the medical probe 302 isdisconnected from the generator 12 (steps 80-88). Alternatively, theexpiration of the elapsed probe usage time T_(E) is determined only onetime per probe connection. That is, once the elapsed probe usage timeT_(E) is determined not to be expired, the medical probe 302 can beoperated without limitation until the medical probe 302 is physicallydisconnected from, and again connected, to the generator 12 (step 90).

In this manner, the physician has a certain amount of time in which tooperate the medical probe 302 after initiation of the probe usagelimitation component 51, notwithstanding the fact that the medical probe302 can be repeatedly disconnected from and reconnected to the generator12. Thus, re-usage of the medical probe 302 can be minimized withoutprematurely rendering the medical probe 302 inoperable.

Limiting Re-use of Devices Based On Detecting Environment Changes

Referring to FIG. 4, the medical probe system 300 is capable ofidentifying and disabling re-used single use devices based on detectingenvironmental changes. In this regard, the probe usage limitationcomponent 51 is capable of detecting an environmental condition to whichthe medical probe 302 is exposed, and determines if the environmentalcondition is indicative of exposure of the medical probe 302 to asterilization cycle.

In a typical sterilization procedure, the medical probe 302 is placedinside a breathable pouch, and a biological indicator is applied to themedical probe 302 according to a validated hospital procedure. Themedical probe 302 and pouch are then placed inside a sterilizationchamber and exposed to a sterilization cycle. The sterilization cyclemay, for example, include preconditioning, exposure, post-vacuum, andaeration steps, which are performed under a variety of environmentalconditions. For example, the preconditioning step may involve subjectingthe medical probe 302 to a temperature of 125-145° F., humidity of55-75%, and a pressure (vacuum) at 1.9-3.9 p.s.i.a. for 30-45 minutes.The exposure step may involve subjecting the medical probe 302 to anoxide, such as, e.g., 100% ethylene oxide (EO) at 600 mg/L, and atemperature of 125-145° F. for four hours. The post-vacuum step mayinvolve twice subjecting the medical probe 302 to a pressure (vacuum) of1.9-3.9 p.s.i.a. The aeration step may involve subjecting the medicalprobe 302 to a temperature of 120° F.-145° F. for twelve hours.

Thus, if the probe usage limitation component 51 detects anenvironmental condition that is indicative of a sterilization cycle,such as, e.g., temperature, humidity, pressure or chemical, then theprobe usage limitation component 51 stores a probe sterilizationindicator 15 indicating that the medical probe 302 has been sterilized.For example, if the probe usage limitation component 51 detects one ormore of the following conditions: a temperature above 125° F., ahumidity above 55%, a pressure below 3.9. p.s.i.a., or an oxide, suchas, e.g., EO, the probe usage limitation component 51 stores a probesterilization indicator I_(S).

Preferably, as part of the post-manufacturing process, the medical probe302 is subjected to an initial sterilization cycle. In this case, themedical probe 302 will be shipped to the physician with the probesterilization indicator I_(S) stored in the probe usage limitationcomponent 51. The control circuit ultimately limits re-usage of themedical probe 302, based on a detection of a re-sterilization of themedical probe 302, an indication that the physician is attempting tooperate the medical probe 302 illegitimately. A medical probe 302 thathas been re-sterilized (the operation of which would be consideredillegitimate operation of the medical probe 302) must be distinguishedfrom a medical probe 302 that has been sterilized only once as a part ofthe post-manufacture process (the operation of which would be consideredlegitimate). In this regard, as will be discussed in further detailbelow, the probe usage limitation component 51 is configured for storinga previous probe usage indicator I_(U), indicating that the medicalprobe 302 has been previously operated and allowing post-manufacturingsterilization to be distinguished from re-sterilization of the medicalprobe 302.

In the illustrated embodiment, the probe usage limitation component 51comprises battery-operated non-volatile RAM with environmental sensingcapabilities. A non-limiting example of such a probe usage limitationcomponent 51 is an electrolytic sensor or chemFET.

The control circuit 68 is configured for reading data from the probeusage limitation component 51 and determining if the data comprises theprobe sterilization indicator I_(S) and the previous probe usageindicator I_(U), and generating an interlock control signal S_(C) basedon the presence of the probe sterilization indicator I_(S) and theprevious probe usage indicator I_(U) within the data read from the probeusage limitation component 51. In particular, the interlock controlsignal S_(C) is generated if both the probe sterilization indicatorI_(S) and the previous probe usage indicator I_(U) are present, or ifboth the probe sterilization indicator I_(S) and the previous probeusage indicator I_(U) are not present. The interlock control signalS_(C) is not generated if the probe sterilization indicator I_(S) ispresent and the previous probe usage indicator I_(U) is not present, orif the probe sterilization indicator I_(S) is not present and theprevious probe usage indicator I_(U) is present.

With reference to FIG. 5, operation of the medical probe 302 duringsterilization will now be described. After manufacture of the medicalprobe 302, the probe usage limitation component 51 carried by themedical probe 302 is continuously detecting an environmental conditionto which the medical probe 302 is exposed (step 92). The environmentalcondition detected by the probe usage limitation component 51 can be,e.g., temperature, pressure, moisture and/or chemical-based. The probeusage limitation component 51 then determines if the environmentalcondition detected is associated with a sterilization cycle, i.e., ifthe environmental condition matches a known environmental condition towhich probes are subjected during the sterilization cycle (step 94). Ifthe probe usage limitation component 51 detects an environmentalcondition associated with the sterilization cycle, such as, e.g., atemperature of 130° F., the probe usage limitation component 51 storesthe probe sterilization indicator I_(S), indicating that the medicalprobe 302 has been either sterilized, whether it be legitimately duringthe post-manufacture process or illegitimately during a re-sterilizationprocess (step 96). This sterilization indicator I_(S) is reported laterto the generator 12 to indicate that the medical probe 302 has beensterilized. The probe usage limitation component 51 continuously detectsand determines if the environmental condition to which the medical probe302 is exposed is associated with a sterilization cycle.

With reference to FIG. 6, operation of the medical probe system 300, inidentifying and disabling re-used single use devices based on detectingenvironmental changes, will now be described. Without knowledge ofwhether the medical probe 302 has been sterilized or previouslyoperated, the medical probe system 300 is set up by physicallyconnecting the medical probe 302 to the generator 12 and powering on thegenerator 12 (step 98). At this point, the generator 12 is in standbymode. The generator 12 then reads the data from the probe usagelimitation component 51 (step 100). After insertion of the medical probe302 within the patient's body and placement of the ablation electrode 16in contact with the tissue to be ablated, the RF power control button 44(shown in FIG. 1) is depressed to conditionally initiate powertransmission from the generator 12 and subsequent delivery of RF energyto the tissue (step 102). At this point, the generator 12 is in deliverymode.

The generator 12 then determines whether the probe sterilizationindicator I_(S) is present in or absent from the data read from theprobe usage limitation component 51, and thus whether the medical probe302 has been sterilized (step 104). If the probe sterilization indicatorI_(S) is present, the generator 12 determines whether the previous probeusage indicator I_(U) is present in the data read from the probe usagelimitation component 51, and thus whether the medical probe 302 has beenpreviously operated (step 106). If the previous probe usage indicatorI_(U) is absent, the medical probe 302 is determined to be sterilizedand unused. Thus, the generator 12 allows operation of the medical probe302, i.e., the interlock control signal S_(C) is not generated (step108).

The generator 12 then writes the previous probe usage indicator I_(U) tothe probe usage limitation component 51 (step 110). In this manner, ifthe medical probe 302 is physically disconnected and reconnected to thegenerator 12 or like generator and conditionally operated, eitherlegitimately or illegitimately, the generator 12 or like generator canascertain that the medical probe 302 has been previously operated. Thegenerator 12 also clears the probe sterilization indicator I_(S) fromthe probe usage limitation component 51 (step 112). In this manner, ifthe medical probe 302 is physically disconnected and reconnected to thegenerator 12 without undergoing a sterilization cycle, the medical probe302 will not be prematurely rendered inoperable, which would otherwiseresult from the presence of the previous probe usage indicator I_(U).That is, as will be discussed in further detail below, if the probesterilization indicator I_(S) is absent and the previous probe usageindicator I_(U) is present, the medical probe 302 can still be operated.

In the illustrated embodiment, storage of the previous probe usageindicator I_(U) into the probe usage limitation component 51 occurs uponeffective operation of the medical probe 302, i.e., operation of themedical probe 302 in such a manner as to form a lesion on the tissue. Inthis regard, to prevent premature storage of the previous probe usageindicator I_(U) into the probe usage limitation component 51, thegenerator 12 does not write to the probe usage limitation component 51during non-therapeutic operation of the medical probe 302, i.e., whenfaulty operation of the medical probe 302 does not result in a tissuelesion. Such faulty probe operation can be caused by a variety ofreasons including, inadequate contact between the ablation electrode 16and the tissue, inadequate energy delivery to the ablation electrode 16and inadequate duration of energy application.

If the previous probe usage indicator I_(U) is present (step 106), themedical probe 302 is determined to have been previously used andre-sterilized illegitimately, and thus, the generator 12 preventsoperation of the medical probe 302, i.e., the interlock control signalS_(C) is generated (step 114).

If the probe sterilization indicator I_(S) is absent (step 104), thegenerator 12 determines if the previous probe usage indicator I_(U) ispresent in, or absent from, the data read from the probe usagelimitation component 51 (step 116). If the previous probe usageindicator I_(S) is present, the medical probe 302 is determined to havebeen physically disconnected from, and reconnected to, the generator 12in the middle of a procedure, and thus further operation of the medicalprobe 302 is legitimate. As such, the generator 12 allows operation ofthe medical probe 302, i.e., the interlock control signal S_(C) is notgenerated (step 118).

If, after the probe sterilization indicator I_(S) is determined to beabsent, the previous probe usage indicator I_(U) is absent, the medicalprobe 302 is determined to be improperly initially sterilized or notsterilized at all, and thus, the generator 12 prevents operation of themedical probe 302, i.e., the interlock control signal S_(C) is generated(step 120).

In this manner, as long as the medical probe 302 is not re-sterilized,the physician can operate the medical probe 302 after initiation of theprobe usage limitation component 51, notwithstanding the fact that themedical probe 302 can be repeatedly disconnected from and reconnected tothe generator 12. Thus, re-usage of the medical probe 302 can beminimized without prematurely rendering the medical probe 302inoperable.

The medical probe system 300 can use other probe indicators incombination with the probe sterilization indicator I_(S) to identify anddisable re-used single use devices based on detecting environmentalchanges. For example, when the medical probe 302 is manufactured, theestimated sterilization date of the medical probe 302, or alternatively,the manufacture date of the medical probe 302, can be stored in theprobe usage limitation component 51. A typical estimated probesterilization date is a month after the manufacture date of the probe.Upon actual sterilization of the medical probe 302, the probesterilization indicator I_(S) and the date of actual sterilization arestored in the probe usage limitation component 51. Upon connection ofthe medical probe 302 to the RF generator 12, if the probe sterilizationindicator I_(S) is absent, the medical probe 302 is determined to beun-sterilized, and therefore is prevented from being operated. If thesterilization indicator I_(S) is present and the actual date ofsterilization is later the estimated actual date of sterilization, themedical probe 302 is determined to be re-sterilized, and therefore isprevented from being operating.

The probe sterilization indicator I_(S) cannot only be used to limitre-usage of medical probes 302, but can also be used to enforce theshelf-life of medical probes 302. In this regard, upon sterilization ofthe medical probe 302, the sterilization indicator I_(S) and actual dateof sterilization can be stored in the probe usage limitation component51. If, upon connection of the medical probe 302 to the RF generator 12,the difference between the actual sterilization date and the currentdate exceeds a predetermined period of time (i.e., the shelf-life of themedical probe 302), the medical probe 302 is prevented from beingoperated.

Limiting Re-use of Devices Based On Cataloging Catheter Usage

Referring to FIGS. 7 and 8, the medical probe system 300 isalternatively capable of identifying and disabling re-used single usedevices based on cataloging catheter usage. In this regard, the controlcircuit 68 includes a catalog 122 (shown in further detail in FIG. 8),obviating the need for a probe usage limitation component 51 within themedical probe. In this embodiment, the control circuit 68 is configuredfor storing historical operational indicators I_(O) obtained from amultitude of medical probes 302 previously operated with the generator12. In the illustrated embodiment, a set of historical operationalindicators I_(O) are stored for each of the multitude of previouslyoperated medical probes 302. Each set of historical operationalindicators I_(O) includes a probe identification code C_(I) andsupplementary historical operational indicators I_(SO). Each probeidentification code C_(I) not only provides historical operationalinformation about the respective medical probe 302, but also provides ameans to cross-reference the supplementary historical operationalindicators I_(SO) within the respective set of historical operationalindicators I_(O), as will be described in further detail below.

The supplementary operational indicators I_(SO) provide historicaloperational information concerning the operation of a medical probe 302,in addition to that provided by the presence of a cataloged probeidentification code C_(I). By way of non-limiting example, asupplementary operational indicator I_(O) can be the initial probe usagetime T_(I) described previously above. Alternatively, a supplementaryoperational indicator I_(SO) can be an incremental probe usage U_(I),which represents the number of times a respective medical probe 302 hasbeen operated. As will be described in further detail below, thehistorical operational indicators I_(SO) can provide historicaloperational information of a selected medical probe 302 to a physician.The historical operational indicators I_(SO) can be further used toconditionally operate the selected medical probe 302.

The catalog 122 is configured for retaining the probe historicaloperational indicators I_(O), notwithstanding disconnection of themedical probe 302 from the generator 12. Thus, storage of the historicaloperational indicators I_(O) within the catalog 122 for subsequent useobviates the need to store historical operational information within themedical probe 302 itself, thereby minimizing probe expense. Forinstance, absent the requirement to store historical operationalinformation in the electronic storage componentry of the medical probe302, a ROM or one or more resistors, which are relatively inexpensive,can be used as the probe identification component 50, merely for storageof the probe identification code C_(I).

The control circuit 68 is configured for, upon connection of a selectedmedical probe 302 to the generator 12, reading the probe identificationcode T_(I), from the probe identification component 50 of the selectedmedical probe 302. The control circuit 68 is further configured for,upon initial operation of the selected medical probe 302, storing theprobe identification code C_(I) in the catalog 122 as a historicaloperational indicator I_(O), the presence of which indicates that theselected medical probe 302 has been previously operated with thegenerator 12.

The control circuit 68 is also configured for obtaining additionalhistorical operational information concerning the operation of theselected medical probe 302, and storing this information in the catalog122 as supplemental historical operational indicators I_(SO). Forinstance, upon initial operation of the selected medical probe 302, thecontrol circuit 68 can obtain the time of initial operation of theselected medical probe 302, which can then be stored in the catalog 122as an initial probe usage time T_(I) next to the probe identificationcode C_(I) corresponding to the selected medical probe 302. Also, eachtime the selected medical probe 302 is operated, the control circuit 68can obtain a cumulative number of times the selected medical probe 302has been operated, which can then be stored in the catalog 122 as anincremental probe usage U_(I) next to the probe identification codeC_(I) corresponding to the selected medical probe 302. Thus, a set ofhistorical operational indicators I_(O) for the selected medical probe302 can be stored in the catalog 122.

The control circuit 68 is also configured for recalling historicaloperational information about a selected medical probe 302, which hasbeen stored in the catalog 122 as the set of historical operationalindicators I_(O). In particular, the control circuit 68 can determine ifthe medical probe 302 has been previously operated with the generator 12by determining if the probe identification code C_(I) read from themedical probe 302 matches any of the probe identification codes C_(I)stored in the catalog 122. The control circuit 68 can also determineadditional historical operational information, such as, e.g., theinitial time of operation of the medical probe 302 or the number oftimes the medical probe 302 has been previously operated, by obtainingthe supplemental operational indicators I_(O), associated with thematched probe identification code C_(I). The recalled historicaloperational information can optionally be displayed on the display (notshown) for viewing by the physician.

The control circuit 68 is further configured for conditionally operatingthe selected medical probe 302, based on the set of historicaloperational indicators I_(O) corresponding to the selected medical probe302. That is, the control circuit 68 is configured for generating aninterlock control signal S_(C) based on the probe identification codeC_(I) and/or associated supplemental operational indicators I_(SO). Aswill be discussed in further detail below, conditional operation of themedical probe 302 can not only be accomplished during the initialconnection between the medical probe 302 and the generator 12, but canalso be accomplished during reconnection between the medical probe 302and the generator 12 (by recalling from the catalog 122), since thecataloged historical operational information is not lost upondisconnection of the medical probe 302 from the generator 12.

By way of non-limiting example, the control circuit 68 can conditionallyoperate the selected medical probe 302, based on the probeidentification code C_(I) and the probe sterilization indicator I_(S),which is stored in the selected medical probe 302 and read out by thecontrol circuit 68, as previously discussed above. In particular, asdiscussed above, a presence of the probe identification code C_(I) inthe catalog 122 indicates that the selected medical probe 302 has beenpreviously operated. A presence of the probe sterilization indicatorI_(S) in the selected medical probe 302 indicates that the selectedmedical probe 302 has been previously sterilized in this manner, use ofthe probe identification code T_(I), allows a medical probe that hasbeen legitimately sterilized by a post-manufacture process to bedistinguished from a medical probe that has been illegitimatelyre-sterilized after usage. Upon operation of the selected medical probe302, the control circuit 68 stores the probe identification code T_(I),in the catalog 122 and clears the probe sterilization indicator I_(S)from the selected medical probe 302, so that the selected medical probe302 is not prematurely rendered inoperable through legitimate adjustmentof the connection between the selected medical probe 302 and thegenerator 12.

Operation of.the selected medical probe 302 is prevented if both theprobe sterilization indicator I_(S) and the probe identification codeC_(I) are present (indicating that the selected medical probe 302 hasbeen re-sterilized), or if both the probe sterilization indicator I_(S)and the probe identification code C_(I) are not present (indicating thatthe selected medical probe 302 has never been sterilized). Operation ofthe selected medical probe 302 is allowed if the probe identificationcode C_(I) is present and the probe identification code T_(I), is notpresent (indicating that the medical probe has only been sterilized onceand never operated), or the probe sterilization indicator I_(S), is notpresent and the probe identification code C_(I) is present (indicatingthat the medical probe has only been sterilized once and is currentlybeing used in an initial procedure).

By way of further non-limiting example, the control circuit 68 canconditionally a operate the selected medical probe 302, based on theinitial probe usage time T_(I) and the predetermined elapsed time limitT_(L), which may be encoded in the probe identification code C_(I) ofthe selected medical probe 302, as previously discussed above. Uponinitial operation of the selected medical probe 302, the control circuit68 stores the initial probe usage time T_(U), along with the probeidentification code T_(I), in the catalog 122. The control circuit 68prevents operation of the selected medical probe 302 when thepredetermined elapsed time limit T_(L) is expired. Expiration of thepredetermined elapsed time limit T_(L) occurs when the differencebetween the initial probe usage time T_(I) and a reference time exceedsthe predetermined elapsed time limit T_(L).

By way of further non-limiting example, the control circuit 68 canconditionally operate the selected medical probe 302, based on theincremental probe usage U_(I) and a predetermined maximum usage limitU_(L), which may be encoded in the probe identification code C_(I) ofthe selected medical probe 302. Upon initial operation of the selectedmedical probe 302, the control circuit 68 stores a “1” as theincremental probe usage U_(I), along with the probe identification codeT_(I), in the catalog 122. Upon each subsequent operation of theselected medical probe 302, the control circuit 68 increments theincremental probe usage U_(I), by one. The control circuit 68 preventsoperation of the selected medical probe 302 when the incremental probeusage U_(I) exceeds the predetermined maximum usage limit U_(L).

Further details regarding the use of an incremental probe usage U_(I)and a predetermined maximum usage limit U_(L) is further disclosed inU.S. Pat. No. 5,383,874, entitled “Systems for Identifying Catheters andMonitoring Their Use,” which issued Jan. 24, 1995, and which is herebyfully and expressly incorporated herein by reference.

With reference to FIG. 9, operation of the medical probe system 300, inidentifying and disabling re-used single use devices based on catalogingcatheter usage, will now be described. The medical probe system 300 isset up by physically connecting a selected medical probe 302 (thehistorical operation of which is not known) to the generator 12 andpowering on the generator 12 (step 124). At this point, the generator 12is in standby mode. The generator 12 then reads the probe identificationcode C_(I) from the probe identification component 50 of the selectedmedical probe 302, i.e., obtains the selected probe identification codeC_(I) (step 126). After insertion of the selected medical probe 302within the patient's body and placement of the ablation electrode 16 incontact with the tissue to be ablated, the RF power control button 44(shown in FIG. 1) is depressed to conditionally initiate powertransmission from the generator 12 and subsequent delivery of RF energyto the tissue (step 128). At this point, the generator 12 is in deliverymode.

The generator 12 then obtains historical operational information for theselected medical probe 302 from the catalog 122 (steps 130-134). Thatis, the catalog 122 is searched to determine if the selected probeidentification code C_(I) matches a cataloged probe identification codeC_(I) (step 130). If the selected probe identification code C_(I) doesmatch a cataloged probe identification code T_(I), the set of historicaloperational indicators I_(O) associated with the matched identificationcode C_(I) (i.e., the set of historical operational indicators I_(O)corresponding to the selected medical probe 302) is obtained (step 132).

As discussed above, the set of historical operational indicators I_(O)comprises the probe identification code T_(I), the presence of whichindicates that the selected medical probe 302 has been previouslyoperated; the initial probe usage time T_(I), indicating that time ofinitial operation of the selected medical probe 302; and the incrementalprobe usage U_(I), indicating the number of times the selected medicalprobe 302 has been previously operated. This historical operationalinformation can be optionally displayed on the display (not shown) forviewing by the physician.

If the selected probe identification code C_(I) does not match acataloged probe identification code T_(I), the selected medical probe302 is deemed to have not been previously operated, and a set ofhistorical operational indicators I_(O) corresponding to the selectedmedical probe 302 does not exist. This historical operationalinformation can be optionally displayed on the display (not shown) forviewing by the physician.

The generator 12 then determines whether or not the selected medicalprobe 302 should be operated, based on the historical operationalinformation obtained from the catalog 122 (step 134). For example, asdiscussed above, the generator 12 can conditionally operate the selectedmedical probe 302, based on the presence of the probe identificationcode C_(I) in the catalog 122 and a presence of the probe sterilizationindicator I_(S) in the selected medical probe 302; and/or based on theinitial probe usage-time T_(I) and the predetermined elapsed usage limitT_(L); and/or the incremental probe usage U_(I) and the predeterminedmaximum usage limit U_(L).

If the generator 12 determines that the selected medical probe 302 canbe operated, the generator 12 allows operation of the selected medicalprobe 302, i.e., the interlock control signal S_(C) is not generated(step 136). If operation of the selected medical probe 302 is the firsttime that the selected medical probe 302 has been operated, i.e., if theselected probe identification code C_(I) did not match a cataloged probeidentification code C_(I) (step 138), the catalog 122 is initializedwith a set of historical operational indicators I_(O) corresponding tothe selected medical probe 302, based on the operation of the selectedmedical probe (step 140). That is, the selected probe identificationcode C_(I), along with the time of initial operation and number of timesthe selected medical probe 302 has been operated (1 time in this case),is stored in the catalog 122.

In the illustrated embodiment, initialization of the catalog 122 withthe set of historical operational indicators I_(O) occurs upon effectiveoperation of the medical probe 302, i.e., operation of the medical probe302 in such a manner as to form a lesion on the tissue. In this regard,to prevent premature initialization of the catalog 122, the set ofhistorical operational indicators I_(O) is not stored in the catalog 122during non-therapeutic operation of the medical probe 302, i.e., whenfaulty operation of the medical probe 302 does not result in a tissuelesion. Such faulty probe operation can be caused by a variety ofreasons, including inadequate contact between the ablation electrode 16and the tissue, inadequate energy delivery to the ablation electrode 16and inadequate duration of energy application.

If operation of the selected medical probe 302 is not the first timethat the selected medical probe 302 has been operated, i.e., if theselected probe identification code C_(I) did match a cataloged probeidentification code C_(I) (step 138), the generator 12 updates the setof historical operational indicators I_(O) corresponding to the selectedmedical probe 302 (step 142). For instance, the incremental probe usageU_(I) may be incremented by one. If the generator 12 determines that theselected medical probe 302 cannot be operated (step 134), the generator12 prevents operation of the selected medical probe 302, i.e., theinterlock control signal S_(C) is generated (step 144).

The generator 12 periodically determines (e.g., every second, whenoperation of the selected medical probe 302 is based on the initialprobe usage time T_(I), and every time the selected medical probe 302,when operation of the selected medical probe 302 is based on theincremental probe usage U_(I)) whether the selected medical probe 302should be operated, and conditionally allows operation of the medicalprobe 302, based on the set of historical operational indicators I_(O),until the selected medical probe 302 is disconnected from the generator12 (steps 134-144). Alternatively, the generator 12 determines whetherthe selected medical probe 302 should be operated only one time perprobe connection. That is, once operation of the selected medical probe302 is allowed, the selected medical probe 302 can be operated withoutlimitation until the selected medical probe 302 is physicallydisconnected from, and again connected to, the generator 12 (step 146).

Preventing Automatic Identification of Devices

Referring to FIG. 10, the medical probe system 300 is alternativelycapable of preventing automatic identification of re-used single usedevices. In this regard, the probe usage limitation component 51 is adisabling circuit, the activation of which disables the probeidentification component 50 by modifying the manner in which the probeidentification component 50 functions. In the illustrated embodiment,the disabling circuit 51 is a switch that changes the output of theprobe identification component 50. For example, if the probeidentification component 50 comprises one or more resistors, thedisabling circuit 51 can change the output resistance value seen by thegenerator 12 by shorting the output of the one or more resistors. Ofcourse, if probe identification component 50 comprises a microchip, oneor more pins of the microchip can be shorted to create the same effect.

Disablement of the probe identification component 50 prevents thecorrect probe identification code C_(I) from being read therefrom,which, as will be discussed in further detail below, precludes themedical probe 302 from being operated. Prior to initial operation of themedical probe 302, the disabling circuit 51 is configured to enable theprobe identification component 50. That is, the disabling circuit 51provides an open circuit to the output of the probe identificationcomponent 50. A non-limiting example of a disabling circuit 51 is anelectrolytic switch. Application of a disable signal S_(D) on thedisabling circuit 51 from an external source, i.e., the generator 12,activates the disabling circuit 51. Preferably, once the disablingcircuit 51 is activated, disablement of the probe identificationcomponent 50 is continued even when the power is removed from thedisabling circuit 51. In this manner, no generator 12 will be able toread the probe identification code C_(I) from the probe identificationcomponent 50 after the probe identification component 50 has beendisabled.

The control circuit 68 is configured for determining whether the medicalprobe 302 has been previously used, i.e., whether the medical probe 302has been used to render a complete procedure on a patient. The controlcircuit 68 can determine whether the medical probe 302 has beenpreviously used by employing a variety of techniques.

By way of non-limiting example, the control circuit 68 can base thedetermination of whether the medical probe 302 has been previously usedon the time elapsed after an initial operation of the medical probe 302,as discussed above. In particular, upon initial operation of the medicalprobe 302, the control circuit 68 stores an initial probe usage timeT_(I) in the medical probe 302 (either in the probe identificationcomponent 50 or other electronic storage componentry), or in a catalogwithin the control circuit 68, along with the probe identification codeC_(I), which can then be later read out by the control circuit 68. Thecontrol circuit 68 then determines if a predetermined elapsed time limitT_(L) (which may be encoded into the probe identification code C_(I))has expired, i.e., if the difference between the initial probe usagetime T_(I) and a reference time exceeds the predetermined elapsed timelimit T_(L). The medical probe 302 is determined to have been previouslyused when the predetermined elapsed time limit T_(L) has expired.

By way of further non-limiting example, the control circuit 68 can basethe determination of whether the medical probe 302 has been previouslyused on a number of times the medical probe 302 has been operated, asdiscussed previously. In particular, upon initial operation of themedical probe 302, an incremental probe usage U_(I) can be stored in themedical probe 302 (either in the probe identification component 50 orother electronic storage componentry), or a catalog, along with theprobe identification code C_(I), which can then be later read out by thecontrol circuit 68. Each time the medical probe 302 is operated, i.e.,each time power is applied to the medical probe 302, the control circuit68 increments the incremental probe usage U_(I) by one. The controlcircuit 68 then determines if the incremental probe usage U_(I) exceedsa predetermined probe usage limit U_(L) (which may be encoded into theprobe identification code C_(I)). The medical probe 302 is determined tohave been previously used when incremental probe usage U_(I) exceeds thepredetermined probe usage limit U_(L).

By way of further non-limiting example, the control circuit 68 can basethe determination of whether the medical probe 302 has been previouslyused on both a previous operation of the medical probe 302 and aprevious sterilization of the medical probe 302, as discussedpreviously. In particular, upon initial operation of the medical probe302, a probe usage indicator I_(U) is stored in the medical probe 302(either in the probe identification component 50 or other electronicstorage componentry), or a catalog in the form of the probeidentification code C_(I), which can then be later read out by thecontrol circuit 68. Upon sterilization of the medical probe 302, a probesterilization indicator I_(S) is stored in the medical probe 302,preferably in an environmentally sensing microchip, which can be laterread out by the control circuit 68. In this manner, use of the probeidentification code C_(I) allows a medical probe that has beenlegitimately sterilized by a post-manufacture process to bedistinguished from a medical probe that has been illegitimatelyre-sterilized after usage.

Upon operation of the medical probe 302, the control circuit 68 storesthe probe identification code C_(I) in the medical probe 302 or catalog122 and clears the probe sterilization indicator I_(S) from the medicalprobe 302 or catalog, so that the medical probe 302 is not prematurelyrendered inoperable through legitimate adjustment of the connectionbetween the medical probe 302 and the generator 12. The medical probe302 is determined to have been previously used if both the probesterilization indicator I_(S) and the previous probe usage indicatorI_(U) are present (indicating that the medical probe 302 has beenre-sterilized), or if both the probe sterilization indicator I_(S) andthe previous probe usage indicator I_(U) are not present (indicatingthat the medical probe 302 has never been sterilized).

As will be discussed in further detail below, previous probe use can beperiodically determined after connection of the medical probe 302 to thegenerator 12, but before disconnection of the medical probe 302 from thegenerator 12. Alternatively, previous probe use is only determined onceupon connection of the medical probe 302 to the generator 12.

The control circuit 68 is further configured for generating the disablesignal S_(D) based on the determination of whether the medical probe 302has been previously used. In particular, if the medical probe 302 isdetermined to have been previously used, the control circuit 68generates the disable signal S_(D), thereby activating the disablingcircuit 51. As discussed above, activation of the disabling circuit 51disables the probe identification component 50, thereby preventing theprobe identification code C_(I) from being read from the probeidentification component 50. If the medical probe 302 is determined notto have been previously used, the control circuit 68 does not generatethe disable signal S_(D), thereby maintaining the inactivation of thedisabling circuit 51. As discussed above, inactivation of the disablingcircuit 51 enables the probe identification component 50, therebyallowing the correct probe identification code C_(I) to be read from theprobe identification component 50.

In alternative embodiments, the disabling circuit 51 can be eliminatedby configuring the control circuit 68 to directly disable the probeidentification.component 50 by modifying the probe identification codeC_(I) in the probe identification component 50 (shown by dashed line).Preferably, this can be accomplished by clearing the probeidentification code C_(I) from the probe identification component 50. Inthis case, the probe identification component 50 preferably comprises amicrochip, such as, e.g., an EEPROM, which is non-volatile, yet easilyallows data to be written thereto. Alternatively, the probeidentification component 50 can be a digital circuit that outputs apulse train or a laser-trimmed clock. Even more alternatively, the probeidentification component 50 can be a solid-state component, such as,e.g., a variable resistor, an array of resistors or a laser-trimmedresistor.

In further alternative embodiments, the disabling circuit 51 comprises amicroprocessor that internally determines whether the medical probe 302has been previously used (i.e., exclusive of a disable signal S_(D)transmitted from the generator 12), and disables the probeidentification component 50, based on this determination. Theprobe-based microprocessor can disable the probe identificationcomponent 50 by modifying the functioning of the probe identificationcomponent 50 itself, such as by. shorting the probe identificationcomponent 50, or by modifying the probe identification code C_(I)storage by the probe identification component 50, such as by clearingthe probe identification code C_(I) therefrom. In this manner, noadditional processing need take place in the generator 12. Thus, astandard generator having the capability of reading a probeidentification code from a medical probe and conditionally operating themedical probe based on the value of the probe identification code, canbe used with the medical probe 302.

The probe-based microprocessor can sense power flow from the generator12 during operation of the medical probe 302, thereby allowing themicroprocessor to detect such probe usage parameters as previous probeoperation, an initial time of probe operation, and a number of times ofprobe operation. The probe-based microprocessor may also have thecapability of detecting sterilization of the medical probe 302. Thus, inthis manner, the probe-based microprocessor can base the determinationof whether the medical probe 302 has been previously operated on anelapsed time after an initial operation of the medical probe 302, on anumber of times the medical probe 302 has been operated, or on aprevious operation of the medical probe 302 and previous sterilizationof the medical probe 302.

The control circuit 68 is further configured for reading the probeidentification code C_(I) from the probe identification component 50when enabled. The control circuit 68 compares the probe identificationcode C_(I) read from the probe identification component 50 with alook-up table of approved probe identification codes. If the probeidentification code C_(I) does not match any of the approved probeidentification codes in the look-up table (either because the wrongmedical probe is being used with the generator 12, or the probeidentification code C_(I) read by the control circuit 68 has beenaltered due to previous probe use), the control circuit 68 does notallow operation of the medical probe 302. That is, the control circuit68 generates an interlock control signal S_(C).

If the probe identification code C_(I) does match any of the approvedprobe identification codes in the look-up table (because the rightmedical probe is used and the probe identification code C_(I) read bythe control circuit 68 has not been altered due to no previous probeuse), the control circuit 68 allows operation of the medical probe 302.That is, the control circuit 68 does not generate an interlock controlsignal S_(C). Further details regarding the conditional operation of amedical probe based on an automatic reading of a probe identificationcode is further disclosed in U.S. Pat. No. 5,383,874, which haspreviously been incorporated herein by reference.

The control circuit 68 is electrically coupled to the interlock device60 and applies the interlock control signal S_(C) thereto. Applicationof the interlock control signal S_(C) activates the interlock device 60,preventing power from being outputted from the power source 52, and inturn, preventing subsequent conveyance of RF energy to tissue in contactwith the ablation electrode 16.

With reference to FIG. 11, operation of the medical probe system 300will now be described. The medical probe system 300 is set up byphysically connecting a medical probe 302 (the historical operation ofwhich is not known) to the generator 12, and powering on the generator12 (step 148). At this point, the generator 12 is in standby mode. Thegenerator 12 then reads the probe identification code C_(I) from theprobe identification component 50 of the medical probe 302 (step 150).After insertion of the medical probe 302 within the patient's body andplacement of the ablation electrode 16 in contact with the tissue to beablated, the RF power control button 44 (shown in FIG. 1) is depressedto conditionally initiate power transmission from the generator 12 andsubsequent delivery of RF energy to the tissue (step 152). At thispoint, the generator 12 is in delivery mode.

The generator 12 then determines if the probe identification code C_(I)read from the probe identification component 50 matches an approvedprobe identification code located in the look-up list (step 154). If theprobe identification code C_(I) does not match an approved probeidentification code (either because the medical probe 302 is notapproved for use with the generator 12 or the probe identificationcomponent 50 located in the medical probe 302 has been disabled due todetection of previous probe usage), the generator 12 prevents operationof the medical probe 302, i.e., the interlock control signal S_(C) isgenerated (step 156). It should be noted that, if the probeidentification component 50 is disabled by shorting, or if the probeidentification code C_(I) is cleared from the probe identificationcomponent 50, the generator 12 will not be able to obtain a value fromthe probe identification component 50, in which case the generator 12need not access the look-up list to ultimately determine that themedical probe 302 should not be operated.

If the probe identification code C_(I) does match an approved probeidentification code (because the medical probe 302 is approved for usewith the generator 12 and had not been determined to have beenpreviously used during a previous connection), the generator 12determines if the medical probe 302 has been previously used based on,e.g., the presence of the probe identification code C_(I) and thepresence of the probe sterilization indicator I^(S); and/or the initialprobe usage time T_(I) and the predetermined elapsed usage limit T_(L);or the incremental probe usage U_(I) and the predetermined maximum usagelimit U_(L), as discussed above (step 158).

If the medical probe 302 is determined not to have been previously used,the generator 12 allows operation of the medical probe 302, i.e., theinterlock control signal S_(C) is not generated (step 160). If themedical probe 302 is determined to have been previously used, thegenerator 12 prevents operation of the medical probe 302, i.e., theinterlock control signal S_(C) is generated (step 162). In addition, thegenerator 12 disables the probe identification component 50 in themedical probe 302 by transmitting the disable signal S_(D) to thedisabling circuit 51, or alternatively, by clearing the probeidentification code C_(I) from the probe identification component 50(step 164). In this manner, when the medical probe 302 is reconnected toany generator that is configured to automatically read a probeidentification code from a medical probe, including the generator 12,the generator quickly determines that the medical probe 302 has beenpreviously used, and thus prevents the operation thereof (step 156).

The generator 12 periodically determines (e.g., every second, whenoperation of the medical probe 302 is based on the initial probe usagetime T_(I), and every time the medical probe 302, when operation of themedical probe 302 is based on the incremental probe usage U_(I)) whetherthe medical probe 302 has been previously used, and conditionally allowsoperation of the medical probe 302, while also conditionally disablingthe probe identification component 50, based on this determination,until the medical probe 302 is disconnected from the generator 12 (steps158-164). The control circuit 68 can periodically determine whether themedical probe 302 has been determined to have been previously used byperiodically reading the probe identification code C_(I) from the probeidentification component 50, and comparing to the approved probeidentification codes in the look-up list.

Alternatively, the generator 12 determines whether the medical probe 302should be operated only one time per probe connection. That is, onceoperation of the medical probe 302 is allowed, the medical probe 302 canbe operated without limitation until the medical probe 302 is physicallydisconnected from, and again connected to, the generator 12 (step 166).

Limiting Re-use of Multiple Use Devices

Operation of the medical probe system 300 has been described above aslimiting re-use of single use medical probes 302. The medical probesystem 300, however, can be employed to limit re-usage of multiple usemedical probes 302 as well. By way of non-limiting example, the medicalprobe system 300 can comprise a counter that keeps track of the numberof times the medical probe 302 is indicated as being used. If thecounter reaches a maximum limit, the medical probe 302 is prevented frombeing operated.

If the medical probe system 300 limits re-usage of the multiple usemedical probe 302 based on the initial time that a medical probe 302 istherapeutically used, the previous initial probe usage time T_(I) iscleared and a current initial probe usage time T_(I) is stored each timethe maximum predetermined elapsed time limit T_(L) expires. The counter,preferably located in the medical probe 302, keeps track of the numberof times the maximum predetermined elapsed time limit T_(L) expires. Themedical probe system 300 prevents further usage of the medical probe 302once the maximum predetermined elapsed time limit T_(L) has expired andonce the counter has reached a predetermined limit. For example, if thenumber of uses of the medical probe 302 is to be limited to five,operation of the medical probe 302 may be prevented after the counterreaches five.

If the medical probe system 300 limits re-usage of a multiple usemedical probe 302 based on detecting environmental changes, the probesterilization indicator I_(S) is cleared each time the medical probe 302is therapeutically used and restored each time the medical probe 302 issterilized. The counter, preferably located in the medical probe 302,keeps track of the number of times the presence of the probesterilization indicator I_(S) is detected upon operation of the medicalprobe 302. The medical probe system 300 prevents further usage of themedical probe 302 once the presence of both the probe sterilizationindicator I_(S) and the previous probe usage indicator I_(U) isdetected, and the counter has reached a predetermined limit.

Similarly, counters can be employed by the medical probe system 300 inlimited re-usage of multiple use medical probes. 302 based on catalogingprobe usage, in which case multiple counters are preferably located inthe RF generator 12 to respectively keep track of a multiple number ofmedical probes 302. Or a counter can be employed by the medical probesystem 300 in limiting re-usage of a medical probe 302 by preventingautomatic identification of the medical probe 302, in which case thecounter is preferably located in the medical probe 302.

It should further be noted that all of the above-described methods oflimiting re-use of a medical probe can each be employed alone to providea single level safety measure, or alternatively, in combination, toprovide a multiple level safety measure.

While preferred methods and embodiments have been shown and described,it will be apparent to one of ordinary skill in the art that numerousalterations may be made without departing from the spirit or scope ofthe invention. Therefore, the invention is not to be limited except inaccordance with the following claims.

What is claimed is:
 1. A method of limiting usage of a medical probe,comprising: detecting an environmental condition to which the medicalprobe is exposed; electronically storing a probe sterilization indicatorin the medical probe if the detected environmental condition indicatesexposure of the medical probe to a sterilization cycle; electronicallystoring a probe usage indicator in the medical probe if the medicalprobe is operated; determining whether the probe sterilization indicatorand probe usage indicator are present; and conditionally operating themedical probe based on the presence of the probe sterilization indicatorand probe usage indicator.
 2. The method of claim 1, further comprising:electronically storing an actual probe sterilization date in the medicalprobe when the medical probe is sterilized; and determining the actualprobe sterilization date of the medical probe.
 3. The method of claim 2,wherein operation of the medical probe is prevented if the differencebetween actual probe sterilization date and a reference date exceeds apredetermined period of time.
 4. The method of claim 3, wherein thepredetermined period of time is a shelf-life of the medical probe. 5.The method of claim 1, wherein operation of the medical probe is allowedif the probe sterilization indicator is present and the probe usageindicator is absent.
 6. The method of claim 5, wherein the probesterilization indicator is cleared from the medical probe and the probeusage indicator is stored in the medical probe if the probesterilization indicator is present and the probe usage indicator isabsent.
 7. The method of claim 1, further comprising: electronicallystoring an estimated probe sterilization date in the medical probe whenthe medical probe is manufactured; electronically storing an actualprobe sterilization date in the medical probe when the medical probe issterilized; and determining the estimated probe sterilization date ofthe medical probe and the actual probe sterilization date of the medicalprobe.
 8. The method of claim 7, wherein operation of the medical probeis prevented if the actual probe sterilization date is later than theestimated probe sterilization date.
 9. The method of claim 1, whereinoperation of the medical probe is prevented if the probe sterilizationindicator and the probe usage indicator are present.
 10. The method ofclaim 1, wherein operation of the medical probe is prevented if theprobe sterilization indicator and the probe usage indicator are present.11. The method of claim 1, wherein operation of the medical probe isallowed if the probe sterilization indicator is absent and the probeusage indicator is present.
 12. A control unit for connection to amedical probe, the medical probe having electronic storage componentry,the control unit comprising: control circuitry configured toelectrically couple to the electronic storage componentry for readingdata from the electronic storage componentry, and for conditionallyoperating the medical probe based on a presence of a probe sterilizationindicator in the data and a presence of a probe usage indicator.
 13. Thecontrol unit of claim 12, wherein operation of the medical probe isallowed if the probe sterilization indicator is present and the probeusage indicator is absent.
 14. The control unit of claim 13, wherein theprobe sterilization indicator is cleared from the electronic storagecomponentry and the probe usage indicator is stored in the electronicstorage componentry when the medical probe is operated if the probesterilization indicator is present and the probe usage indicator isabsent.
 15. The control unit of claim 13, wherein the probesterilization indicator is cleared from the electronic storagecomponentry and the probe usage indicator is stored in the electronicstorage componentry when the medical probe is effectively operated ifthe probe sterilization indicator is present and the probe usageindicator is absent.
 16. The control unit of claim 12, wherein operationof the medical probe is prevented if the probe sterilization indicatorand the probe usage indicator are present.
 17. The control unit of claim12, wherein operation of the medical probe is prevented if the probesterilization indicator and the probe usage indicator are absent. 18.The control unit of claim 12, wherein operation of the medical probe isallowed if the probe sterilization indicator is absent and the probeusage indicator is present.
 19. The control unit of claim 12, whereinthe control circuitry comprises a microprocessor.
 20. The control unitof claim 12, further comprising: an RF power source; and an interlockingdevice electrically coupled between the RF power source and the controlcircuitry.
 21. A medical probe, comprising: an elongate member having adistally located operative element; and electronic storage componentryconfigured for detecting an environmental condition to which the medicalprobe is exposed and electronically storing a probe sterilizationindicator in the medical probe if the detected environmental conditionindicates exposure of the medical probe to a sterilization cycle, andconfigured for storing a probe usage indicator in the medical probe onlyif an initial operation of the medical probe is detected.
 22. Themedical probe of claim 21, wherein the electronic storage componentry isnon-volatile.
 23. The medical probe of claim 21, wherein the electronicstorage componentry comprises non-volatile RAM coupled to a battery. 24.The medical probe of claim 21, wherein the electronic storagecomponentry comprises an EEPROM coupled to a battery.
 25. The medicalprobe of claim 21, wherein the environmental condition istemperature-based.
 26. The medical probe of claim 21, wherein theenvironmental condition is moisture-based.
 27. The medical probe ofclaim 21, wherein the environmental condition is pressure-based.
 28. Themedical probe of claim 21, wherein the environmental condition ischemical-based.
 29. The medical probe of claim 21, wherein the elongatemember forms a catheter.
 30. The medical probe of claim 21, wherein theelongate member forms a surgical probe.
 31. A method of monitoringsterilization and usage of a medical probe, comprising: detecting anenvironmental condition to which the medical probe is exposed;electronically storing a probe sterilization indicator in the medicalprobe if the detected environmental condition indicates exposure of themedical probe to a sterilization cycle; electronically storing a probeusage indicator in the medical probe only if initial operation of themedical probe is detected; and determining whether the probesterilization indicator and probe usage indicator are present.
 32. Themethod of claim 31, wherein the environmental condition istemperature-based.
 33. The method of claim 31, wherein the environmentalcondition is moisture-based.
 34. The method of claim 31, wherein theenvironmental condition is pressure-based.
 35. The method of claim 31,wherein the environmental condition is chemical-based.
 36. The method ofclaim 31, further comprising preventing usage of the medical probe basedon a presence of the probe sterilization indicator and a presence of theprobe usage indicator.
 37. The method of claim 31, wherein a presence ofthe probe sterilization indicator and probe usage indicator aredetermined when the medical probe is connected to a control unit.